Eudra GMP - Public Layout

MIA | GMP | API REG | WDA | GDP | Sites

Help

Fri 6 Nov 2026 18:08:08 BST

GMP Compliance Menu

GMP Certificates

Non-Compliance Report

Print Preview

Print Preview (Short version)

Back To Search

Swedish Medical Products Agency

CERTIFICATE NUMBER: SE-H-GMP-25-056739

CERTIFICATE OF GMP COMPLIANCE OF A MANUFACTURER(1) , (2)

Part 1

Issued following an inspection in accordance with
Art. 111(5) of Directive 2001/83/EC as amended

The competent authority of Sweden confirms the following:

The manufacturer: AstraZeneca AB

Site address:	Forskargatan 18, Sodertalje, 151 36, Sweden
Additional details on units inspected:	*Respiratory products and secondary packaging*

OMS Organisation Id. / OMS Location Id.: ORG-100001699 / LOC-100000556

Has been inspected under the national inspection programme in connection with manufacturing authorisation no. SE-H-MIA-24-047065 in accordance with Art. 40 of Directive 2001/83/EC.

Is an active substance manufacturer that has been inspected in accordance with Art. 111(1) of Directive 2001/83/EC0.

From the knowledge gained during inspection of this manufacturer, the latest of which was conducted on 2025-05-23 , it is considered that it complies with:

The principles and guidelines of Good Manufacturing Practice laid down in Directive (EU) 2017/1572. (3)

The principles of GMP for active substances referred to in Article 47 of Directive 2001/83/EC and an appropriate level of GMP as referred to in Article 46(f) of Directive 2001/83/EC.

This certificate reflects the status of the manufacturing site at the time of the inspection noted above and should not be relied upon to reflect the compliance status if more than three years have elapsed since the date of that inspection. However, this period of validity may be reduced or extended using regulatory risk management principles by an entry in the Restrictions or Clarifying remarks field. Updates to restrictions or clarifying remarks can be identified through the EudraGMDP website (https://eudragmdp.ema.europa.eu/). This certificate is valid only when presented with all pages and both Parts 1 and 2.

The authenticity of this certificate may be verified in EudraGMDP. If it does not appear, please contact the issuing authority.

__________________________________________________________________________________________________________________________

(1) The certificate referred to in paragraph Art. 111(5) of Directive 2001/83/ECis also applicable to importers.
(2) Guidance on the interpretation of this template can be found in the Interpretation of the Union format for GMP certificate.
(3) These requirements fulfil the GMP recommendations of WHO.

Part 2

Human Medicinal Products

1 MANUFACTURING OPERATIONS

1.2 Non-sterile products

   1.2.1  Non-sterile products (processing operations for the following dosage forms)
           1.2.1.17  Other: multidose powder inhaler(en)
   1.2.2  Batch certification

1.4 Other products or manufacturing activity

1.4.3 Other: See clarifying remarks(en)

1.5 Packaging

   1.5.1  Primary Packaging
           1.5.1.17  Other non-sterile medicinal products: multidose powder inhaler(en)
   1.5.2  Secondary packaging

1.6 Quality control testing

1.6.2 Microbiological: non-sterility
1.6.3 Chemical/Physical

2 IMPORTATION OF MEDICINAL PRODUCTS

2.1 Quality control testing of imported medicinal products

2.1.3 Chemical/Physical

2.3 Other importation activities

2.3.2 Importation of intermediate which undergoes further processing

Manufacture of active substance. Names of substances subject to inspection:

[460056]Budesonide, micronised(en)

[460032]Formoterol fumarate dihydrate, micronised(en)

[460033]Glycopyrronium bromide, micronised(en)

[460057]Terbutaline sulfate, micronised(en)

[460054]Albuterol sulfate, micronised(en)

3. MANUFACTURING OPERATIONS - ACTIVE SUBSTANCES

Active Substance:Budesonide, micronised

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Micronisation and conditioning

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Formoterol fumarate dihydrate, micronised

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Micronisation and conditioning

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Glycopyrronium bromide, micronised

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Micronisation and conditioning

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Terbutaline sulfate, micronised

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Micronisation and conditioning

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Active Substance:Albuterol sulfate, micronised

3.5 General Finishing Steps

3.5.1  Physical processing steps:
Micronisation and conditioning

3.6 Quality Control Testing

3.6.1  Physical / Chemical testing

3.6.2  Microbiological testing excluding sterility testing

Clarifying remarks (for public users):

1.4.3 - Manufacturing covers hormones or substances with hormonal activity. - Manufacturing also includes preparation and spray drying of nonactive substances as porous particles. - Storage of primary and secondary materials is performed at Gärtunavägen, 152 57 Södertälje. 1.6 Quality control testing is performed at addresses Forskargatan 18, 151 36 Södertälje and Gärtunavägen, 152 57 Södertälje.

The EudraGMDP database is maintained and operated by the EMA. Access to the general public is granted in order to enhance availability of information related to the EMA mandate. The content of the database is provided by the National Competent Authorities (NCA) of the EEA. For this reason, the EMA accepts no responsibility or liability whatsoever (including but not limited to any direct or consequential loss or damage it might occur to you and/or any other third party) arising out of or in connection with the information on this database. Any questions about the content should be addressed to the relevant NCA. Please click here to get list of NCA's.

For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.

Documents issued by UK authorities up to and including 31 December 2020 remain available for consultation in EudraGMDP. However, they are no longer included or updated from 1 January 2021, with the exception of the documents pertaining to sites located in Northern Ireland.